Sorin Group, (Reuters Code: SORN.MI), a global medical device company
and a leader in the treatment of cardiovascular diseases, announced
today at Heart Rhythm 2012, the Heart Rhythm Society’s 33rd
Annual Scientific Sessions, the publication of the CLEAR study results,
in Europace, Advance Access publication, 1 May 2012,
doi:10.1093/europace/eus059. The study demonstrates the clinical benefit
of the SonR sensor based cardiac resynchronization therapy (CRT)
optimization system in heart failure (HF) patients2.

SonR is the first and only system to provide weekly automatic
optimization during patient’s daily activities as an alternative to
in-clinic manual echocardiography-based device settings3. The
unique SonR system consists of a dedicated sensor embedded in the tip of
a pacing lead implanted with the CRT device. The sensor’s advanced
technology allows direct measurement of real-time cardiac contractility
and uses this hemodynamic signal to optimize the device’s parameters for
each individual patient at rest and exercise.

The CLEAR clinical study, a prospective, multicenter, single-blind,
randomized study conducted in 51 centres in 8 European countries
enrolled 238 patients with severe HF, i.e., New York Heart Association
(NYHA) functional class III and IV and a left ventricular ejection
fraction (LVEF) <35%. Study results at 1 year showed that with SonR’s
regular automatic optimization of the device’s atrio-ventricular and
inter-ventricular delays, 76% of patients were classified as improved,
compared with 62% in the group of patients with standard CRT programming
(p=0.0285).

“The publication of the CLEAR study is a remarkable milestone in the
treatment of heart failure patients indicated for CRT. The regular
automatic optimization provided by SonR demonstrates significant
increase in the proportion of heart failure patients improving with this
therapy. It is the first time a device-based algorithm has demonstrated
the ability to improve patient outcomes in a prospective, randomized
trial,” commented Philippe Ritter, M.D. University Hospital of Bordeaux,
France and principal investigator of the CLEAR clinical trial.“CRT
optimization is usually performed in non-responder patients through an
expensive, complex and time-consuming echocardiographic procedure. The
SonR system optimization is automatic, individualized and performed on a
regular basis by the device in all patients. It has the potential to
reduce the number of echocardiographic procedures and its related
costs,” he added.

“We are very satisfied with the results of the prospective, randomized
CLEAR trial which demonstrates that the SonR system provides unique
clinical benefit for CRT patients. These results clearly highlight our
ongoing commitment to innovation in the hemodynamic management of heart
failure patients,” said Stefano Di Lullo, Sorin Group, President of the
CRMBusinessUnit.

About CRT Therapy

Cardiac resynchronization therapy is a therapy that delivers timely
electrical pulses to the chambers of the heart. This allows the heart to
beat in a more coordinated and synchronized manner, thus more
effectively. Studies have shown that around one-third of patients with
advanced heart failure do not effectively respond to CRT45.
In order to improve therapy success rate, it is important to offer each
patient a tailor-made programming of the timing between electrical
impulses sent to different parts of the heart (CRT settings) on a
regular basis. Current optimization methods include echocardiography and
other device-based timing features. Echocardiography is difficult and
time-consuming while other device-based CRT optimization features have
shown limited benefits6. All of these current methods require
manual steps. They are typically performed only once and only while the
patient is resting.

About SonR

The result of a 10-year clinical science program, the SonR sensor
uniquely measures patient’s cardiac muscle vibrations related to the
first heart sound. These real-time measurements are transmitted to the
CRT-D device which uses them to determine the best settings for the
patient. Every week, the system automatically optimizes to adapt to the
patient’s changing condition. SonR measurements correspond to LVdP/dtmax,
the gold standard for assessing left ventricular contractility, a key
indicator of cardiac performance. SonR is the only CRT optimization
system that automatically optimizes patients every week and importantly,
while the patient is active, providing real-life optimization.

About Sorin Group

Sorin Group (www.sorin.com)
is a global, medical device company and a leader in the treatment of
cardiovascular diseases. The Company develops, manufactures, and markets
medical technologies for cardiac surgery and for the treatment of
cardiac rhythm disorders. With 3,750 employees worldwide, Sorin Group
focuses on three major therapeutic areas: cardiopulmonary bypass
(extracorporeal circulation and autotransfusion systems), cardiac rhythm
management, and heart valve repair and replacement. Every year, over one
million patients are treated with Sorin Group devices in more than 80
countries.

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